Micromedics Nasal Septal Button
FDA 510(k) K982667 · Micromedics, Inc.
510(k) numberK982667
Submission
- Device name
- Micromedics Nasal Septal Button
- Applicant
- Micromedics, Inc.
Eagan, MN, US - Received
- July 31, 1998
- Decision date
- November 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFB – Button, Nasal Septal
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code LFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131745 | Blom-Singer Septal Perforation ProsthesisLFB · Traditional | Helix Medical, LLC | 09/17/2013SE |
| K013696 | Silmed Nasal Septal ButtonLFB · Traditional | Silmed, Inc. | 11/28/2001SE |
| K972060 | Nasal Septal ButtonLFB · Traditional | Boston Medical Products, Inc. | 07/03/1997SE |
| K920994 | Hood Nasal Septal ButtonLFB · Traditional | Hood Laboratories | 05/15/1992SE |
| K901366 | Invotec Septal ButtonLFB · Traditional | Invotec International, Inc. | 06/14/1990SE |
| K871072 | Omega Nasal Septal ButtonLFB · Traditional | Omega Silicone, Inc. | 06/08/1987SE |
| K871200 | Cui Nasal Septum ButtonLFB · Traditional | Cox-Uphuff Intl. | 04/15/1987SE |
| K862497 | Microtek Septal ButtonLFB · Traditional | Microtek Medical, Inc. | 07/14/1986SE |
| K850492 | Nasal Septal ButtonLFB · Traditional | Santa Barbara Medco, Inc. | 03/07/1985SE |
| K822637 | Nasal Septal ButtonsLFB · Traditional | Abco Dealers, Inc. | 09/28/1982SE |
More from Abco Dealers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241739 | Endoscopic Applicator, 41 cmGCJ · Special | 07/15/2024SE |
| K123847 | Malleable Tip Endoscopic ApplicatorGCJ · Special | 01/08/2013SE |
| K122526 | 360 Gas Assisted Endoscopic ApplicatorGCJ · Special | 11/16/2012SE |
| K120608 | Endoscopic ApplicatorGCJ · Traditional | 03/15/2012SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | 03/15/2011SE |
| K100754 | Graft Delivery System Model SA-6115FMF · Traditional | 06/09/2010SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | 03/14/2008SE |
| K061092 | Baxter Duplospray Mis ApplicatorFMF · Traditional | 09/13/2006SE |
| K051157 | Instru-Safe Instrument Protection SystemsKCT · Traditional | 09/01/2005SE |
| K050340 | Micromedics Sphenoid Sinus StentKAM · Traditional | 04/27/2005SE |
Questions and answers
When was Micromedics Nasal Septal Button cleared by the FDA?
Micromedics Nasal Septal Button (K982667) received a 510(k) decision of Substantially Equivalent on November 24, 1998, 116 days after the submission was received.
What is the product code of K982667?
The FDA product code is LFB – Button, Nasal Septal, a Unclassified device.